Tikosyn

Product NDC: 69189-5820
11-digit product format: 691895820
Labeler code: 69189
Product ID: 69189-5820_7c329776-808b-4c94-a77b-3c0d403917b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dofetilide
Dosage form: CAPSULE
Route: ORAL
Labeler: Avera McKennan Hospital
Application: NDA020931
Marketing category: NDA
Marketing start: 2016-03-28
Marketing end: 0000-00-00
Substance: DOFETILIDE
Active strength: 1 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69189-5820		I	Inactivated by FDA		2026-08-03
excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 38 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	69189-5820		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69189-5820	69189-5820-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	69189-5820		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69189-5820	69189-5820-1	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020931-001	TIKOSYN	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01
N020931-002	TIKOSYN	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01
N020931-003	TIKOSYN	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020931-001	AB
N020931-002	AB
N020931-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020931-002	TIKOSYN	0.25MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020931-003	TIKOSYN	0.5MG	CAPSULE / ORAL	AB	RLD, RS	1999-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020931-001	TIKOSYN	0.125MG	CAPSULE / ORAL	AB	RLD	1999-10-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020931-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020931-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020931-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020931-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020931-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020931-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020931-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020931-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020931-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020931-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020931-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020931-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020931-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020931-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020931-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020931-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020931-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020931-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020931-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020931-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020931-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020931-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020931-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020931-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020931-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020931-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020931-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020931-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020931-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020931-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020931-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020931-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020931-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020931-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020931-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020931-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020931-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020931-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020931-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020931-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tikosyn	DOFETILIDE	Pfizer Laboratories Div Pfizer Inc	02438044-d6a3-49e9-a1ac-3aad21ef2c8c	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020931 application number: NDA020931

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cdc36b95-20ce-9079-16ec-f3cdb4dcf4fd	Product name	9	20230112

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69189-5820-1	2020-01-31	C162847	48780-1	9d75b9d0-56a7-f424-e053-dadaa90a57ce	TIKOSYN ® (dofetilide) Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69189-5820-1	Tikosyn	1 in 1 DOSE PACK	CAPSULE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69189-5820	TIKOSYN (DOFETILIDE) CAPSULE [AVERA MCKENNAN HOSPITAL]	1	Legacy NDC, 1 package rows	20170411_b77b4388-36ec-4971-90a5-353879adb8b5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R4Z9X1N2ND	DOFETILIDE	115256-11-6	DOFETILIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310005	dofetilide 500 MCG Oral Capsule	PSN	b77b4388-36ec-4971-90a5-353879adb8b5	1
285016	Tikosyn 500 MCG Oral Capsule	PSN	b77b4388-36ec-4971-90a5-353879adb8b5	1
285016	dofetilide 0.5 MG Oral Capsule [Tikosyn]	SBD	b77b4388-36ec-4971-90a5-353879adb8b5	1
310005	dofetilide 0.5 MG Oral Capsule	SCD	b77b4388-36ec-4971-90a5-353879adb8b5	1
310005	dofetilide 500 MCG Oral Capsule	SY	b77b4388-36ec-4971-90a5-353879adb8b5	1
285016	Tikosyn 0.5 MG Oral Capsule	SY	b77b4388-36ec-4971-90a5-353879adb8b5	1
285016	Tikosyn 500 MCG Oral Capsule	SY	b77b4388-36ec-4971-90a5-353879adb8b5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69189-5820-1	69189582001	1 in 1 DOSE PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TIKOSYN ® (dofetilide) Capsules	Avera McKennan Hospital	2017-03-24	HUMAN PRESCRIPTION DRUG LABEL	1